MAUDE Adverse Event Report: 3M HEALTH CARE 3M RANGER(TM) HIGH FLOW BLOOD/FLUID DISPOSABLE SET; HIGH FLOW DISPOSABLE TUBING

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No information was provided.No staff or patient injury occurred.The customer reported two lot #'s, hw8255 and hw8284, were associated with this reported incident.Lot # hw8284 was manufactured on dec 11, 2018 with an expiration date of dec 11, 2021.The sample has not been received by 3m (b)(6) for evaluation.3m was unable to verify the leak location, kink and the identify the root cause without the sample.Analysis is pending on returned samples to verify leakage location.3m will continue to monitor.
Event or Problem Description
Two 3m¿ ranger¿ high flow disposable sets (model 24365) leaked fluid.One set reportedly was discovered to have a kink in the tubing below the auto-venting bubble trap.The employee alleged that set leaked saline at the seam during priming.The employee alleged a second set leaked saline at the seam by the auto-venting bubble trap during priming.No patient or staff injury was alleged.
Event or Problem Description
A hospital employee alleged two 3m¿ ranger¿ high flow disposable sets (model 24365) leaked fluid.One set reportedly was discovered to have a kink in the tubing below the auto-venting bubble trap.The employee alleged that set leaked saline at the seam during priming.The employee alleged a second set leaked saline at the seam by the auto-venting bubble trap during priming.No patient or staff injury was alleged.

• Brand Name: 3M RANGER(TM) HIGH FLOW BLOOD/FLUID DISPOSABLE SET
• Common Device Name: HIGH FLOW DISPOSABLE TUBING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 9309244
• Report Number: 2110898-2019-00132
• Device Sequence Number: 2132237
• Product Code: BSB
• UDI-Device Identifier: 00707387781460
• UDI-Public: 00707387781460
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K973741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 24365
• Device Lot Number: HW8255
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1